Package device and method of making the same



July 18, W67 (3. B. JosT PACKAGE DEVICE AND METHOD OF MAKING THE SAMEFiled Oct. 14, 1965 INVENTOR. 24 32 26 34 2% 336B 35%) 29 CHARLES E.JCS? United States Patent 3,331,499 PACKAGE DEVICE AND METHOD OF MAKINGTHE SAME Charles B. Jest, 9081 Jackson St., Mentor, Ohio 44060 FiledOct. 14, 1965, Ser. No. 495,856 24 Claims. (c1. ace-63.4

The present invention relates to an article holder and more particularlyto an aseptic package device and method of making the same fortransporting elongated objects, such as vaccination needles or the like.

It is often necessary to transport or have available for immediate usesmall applicators or objects which should be sterile when used, butwherein there is neither time, nor facilities for sterilizing theapplicators at the place of use. Examples of such applicators areneedles for plastic hypodermic syringes, vaccination needles, medicatedswabs, and cosmetic and grooming aids. One way of packaging ortransporting such presterilized articles in the past has been to placethem in a large container having no compartments or compartments in opencommunication. Upon opening the container to use one of the items, theaseptic character of the remaining items was damaged or destroyed.Another method was to place the articles in a sponge at the bottom of abox which arrangement was diflicult and cumbersome. Moreover, each timethe box was opened, the medicated or lubricated sponge was exposed tothe deleterious effects of the atmosphere, and any foreign matter whichit might contain, thereby harming or destroying the aseptic character ofthe remaining needles. In addition, such containers were often large anddifficult to carry conveniently in the pocket or purse.

Accordingly, an object of the present invention is to produce an asepticdevice which is sufficiently small and compact in size so as to bereadily carried in the pocket, purse or the like with minimumconsumption of space.

Another object is to package the applicator so that removal of one willnot cause contamination or exposure to the atmosphere of the others.

A further object is to produce a device which prolongs the effectivelife of an applicating medium, such as an antiseptic, which is disposedwithin the device while still permitting continued removal of objectsfrom the device.

A further object is to produce an aseptic container which is relativelyeasy and inexpensive to make but which will accomplish the aforesaidobjects.

A further object is to provide a device having a plurality ofcompartments which does not require the insertion of a separateantiseptic base in each compartment, but which will perform as thoughseparate bases had been installed.

Another object is to provide a single base member which can supportpointed objects to prevent puncture of a polymeric outer sheath, whileat the same time serving as a source of antiseptic and a continuation ofthe compartmentalization seal for a plurality of compartments.

A still further object of the present invention is to provide a novelmethod for making the aseptic device of the character heretoforedescribed.

Briefly stated, the foregoing and other related objects are accomplishedby the provision of a novel aseptic device which comprises a thin,polymeric sheath which is completely closed and which containsinteriorly thereof adjacent one end an antiseptic sponge-like basemember. The device is constructed and arranged to provide a plurality oflongitudinally extending closed compartments each of which communicatessat one end with an adjacent portion of the antiseptic base member, saidspongelike antiseptic base member providing, with the sheath, barrierregions to form continuations of the compart- 3,331,499 Patented July18, 1967 "ice ments to provide a unitary structure, whereby selective ofthe compartments may be readily moved for individua usage of anapplicator.

Other related objects and advantages of the present invention will beapparent from the following description taken in conjunction with theaccompanying drawings, wherein:

FIG. 1 is a fragmentary, generally perspective view of a completepackage device and which shows one of the compartments containing anapplicator in the process of being partially removed;

FIG. 2 is a top plan view of the aseptic container insert with one ofthe aseptic insert compartments in the process of being removed;

FIG. 3 is a longitudinal edge view of one of the insert compartmentsremoved from the device; and

FIG. 4 is an enlarged fragmentary cross-section view taken along theline 44 of FIG. 2, and showing one form in which a novel barrier betweenthe compartments may be made in accordance with the present invention.

Referring then again to the drawings, FIG. 1 is a perspective viewshowing a complete device, designated generally at 8, with one of theapplicators in the process of being partially removed therefrom. Asshown, the device 8 includes an outer cover 10 and an insert, designatedgenerally at 12, having a plurality of compartments 14, 16, 18 and 20.The device 8 includes a continuous medicated and/ or lubricatedsponge-like base member 22 which extends transversely thereof and whichprovides a series of aligned base sections 24, 26, 28 and 29 adapted toreceive an antiseptic material. The respective base sections areintegrally connected together by a series of barrier regions 32, 34 and36a, 36b, which function to retain the antiseptic material in eachcompartment in isolated relationship from one another. As shown, objects30, such as vaccination needles or the like, may be disposed within eachof the respective compartments and inserted at one end into theassociated base section of the base member 22 for the purposes andadvantages as will hereinafter be more fully described.

In the embodiment shown in FIG. 1, the cover 10 may be of the fold-opentype having a back 38 and a stub 40. The stub 40 includes a bottomportion 42 and a front portion 44 with side portions 46 and 48 at theopposed ends thereof. The cover 10 includes a foldable flap 50 having aleading edge 52 adapted to be received between the front portion 44 ofthe stub 40 and the insert 12 so as to provide a protective cover forthe insert 12 in the assembled position thereof. The side portions 46and 48 may be made integral with back 38 and attached to the bottom 42and front 44 portions by means of a suitable adhesive. In the assembledarrangement shown in FIG. 1, the insert 12 is disposed so that one endthereof is contained within the stub 40, whereupon, the flap 50 of thecover 10 may there after be closed or folded over the same simply byinserting the leading edge 52 between the insert 12 and stub 40, asaforesaid.

The aseptic insert 12 is comprised of a series of compartments 14, 16,18 and 20, each of which is sealed from the adjacent compartment, andfrom the outer atmosphere. FIG. 2 shows the insert 12 removed from theouter cover 10. In the illustration, one of the compartments 20 is shownbeing separated from the remaining compartments. The insert 12 comprisesan elongated base member 22 having sponge-like characteristics. Thematerial selected for the base must be non-toxic and one which iscapable of forming a seal in cooperation with the outer sheath 54 of theaseptic insert, as hereinafter set forth. A preferred material for thebase member 22 is a polyurethane foam. The base member 22 may besaturated with an applicating medium, such as an antiseptic, medicant orlubricant material, prior to assembly of the insert 12. An antisepticwould be used where it is desired to maintain the sterility of thecompartments. A medicant would be used where the object 30 is to apply amedication. A lubricant would be used where the purpose is to retain theobject 30 in a moist, lubricated state. It is to be understood that theapplicating medium might be a combination of the aforesaid items.Examples of antiseptics which might be used are sodium hydroxide orhydrochloride.

As shown in FIG. 2, the antiseptic medicant or lubricant impregnatedbase member 22 receives the pointed end of the objects 30, such as thevaccination needles shown. Preferably, the assembly should be made inthe conventional sterilized surroundings in which pharmaceutical devicesare packaged.

The objects 30 and the base member 22 may then be surrounded by theflexible polymeric sheath 54. It is preferred that the sheath 54 benon-toxic and moisture resistant with good resistance to heat and cold.The sheath 54 may be transparent or opaque. Where the medicant orobjects 30 are subject to deterioration upon exposure to sunlight, it ispreferable to utilize a sheath which is opaque, or which is translucentbut transmits a minimum amount of ultraviolet ray energy. It ispreferred that the sheath have a good tensile strength. A preferredmaterial for the outer sheath 54 is Alathon, a trademarked polyethylenefilm of the -Du Pont company.

In one form of assembly, such as illustrated in FIGS. 3 and 4, thesheath 54 may be made from two thin sheets 56 and 58 of polymeric,film-like material. The sheets 56 and 58 are preferably superimposed onone another with the base member 22 and objects 30 disposedtherebetween. As shown in FIG. 2, the sheets 56 and 58 may then beheat-sealed completely around their marginal edges, as at 60, to providethe composite insert 12 shown.

It is preferred that the application of the outer sheath 54 and the heatsealing of the end, be performed in the presence of the atmosphere sothat some air remains inside the sheath. The retention of some airfacilitates subsequent separation of the compartments 14, 16, 18 and 20during use and enables the medicant or antiseptic which is in the basemember 22 to diffuse throughout each compartment so as to retain theentire compartment in a sterile condition. The presence of the air alsofacilitates separation of the compartments as it prevents the sheath 54from collapsing about the objects 35} giving a bodyless, sleazystructure which would otherwise be dificult to separate.

In accordance with the invention, the individually sealed compartments14, 16, 18 and 20 provided within the insert 12 may be readilyaccomplished in a single action. As an example, a heated, pressureapplying means, as the pair of weld bars B and B of FIG. 4, may bebrought into engagement with the superimposed sheets 56 and 58 of thesheath 54 so as to form intercompartmental heat seals, as at 62. Theheat seals 62 extend longitudinally and merge at their opposed ends intothe heat seals 60 provided adjacent the top and bottom margins of thesheath 54 so as to provide the completely enclosed, multicompartmentstructure shown. Application of heat and pressure to the base member 22causes a predetermined compressive fusion of the material thereof so asto form the barrier regions 32, 34 and 36a, 36b, which separate therespective base sections 24, 26, 28 and 29, whereby the single basemember 22 cooperates with the sheath 54 to provide a plurality ofantiseptic compartments each with its own base section for receivingtherein one of the objects 30. Suflicient heat and pressure should beapplied to the sheets 56 and 58 of sheath 54 in the area of the basemember 22 so that the sheets 56 and 58 are fused thereto and provide aseal therewith, whereby the barrier regions 32, 34, and 36a, 36bconstitute, in effect, continuations of the longitudinal,intercompartmental seals 62.

It has been found that a contact pressure, such as about p.s.i. at atemperature of about 125 F. is sufficient to provide the desired sealcharacteristics when polyurethane foam is employed for the base memberand Alathon, a

trademark for polyethylene film by the Du Pont com-' pany, is employedfor the sheets 56 and 58 of the sheath 54. By this arrangement, it isbelieved that the application of heat and pressure in the mannerindicated imparts to the respective barrier regions 32, 34 and 36a,3612, a solid, rigid and fluid impervious construction so that theantiseptic material contained in the base sections 24, 26, 28 and 29 onopposite sides of the respective barrier regions are eflectivelyprevented from intercompantmental migration.

To facilitate separation of the respective compartments 14, 16 and 18,the longitudinal, intercompartmental seals 62 may each be provided witha central, weakened tear line, as at 64, which lines may be readilyformed in the sheets 56 and 58 by the provision of projections P and Pwhich extend from work engaging surfaces of the respective weakened tearlines 64. Thus one of the compartments, such as the compartment 20 shownin FIG. 2, may be removed from the remaining compartments in its closedcondition merely by manually pulling the same laterally in the manner ofa tearing action along the respective weakened line 64, whereby theremaining half of the seal 62, as at 62a, maintains the sealed integrityof the adjacent compartment 18 and its associated adjacent barrierregion 36a while the remaining other half of the seal, as at 6217,maintains the sealed integrity of the removed compartment and itsassociated barrier region 3612. The seals 62 should be of a widthsufiicient to enable separation of the compartments, but without ruptureof the seal. It has been found desirable that when the sheath 54 is madeof Alathon having a thickness of about 0.0002 inch, that the width ofthe seals be approximately onefourth inch.

It is to be understood that instead of having the antiseptic applied asa liquid disposed in the base member 22, it might also be made a part ofthe foam by a compression and heat-seal process, whereby the medicant orantiseptic is fused to the base member.

It is further to be understood that instead of a heatseal for formingthe compartments, it may be possible to use a cold chemical seal, whichis capable of forming barrier regions comparable to the barrier regionsdescribed in connection with the heat-seal.

It is believed that as a result of the heat treatment, each barrierregion, such as 32, is of higher density than the remainder of the basemember 22 so as to become solid as compared to the sponge-like nature ofthe remainder of the base member. Consequently, the barrier regions arerigid, whereas the sections 24, 26, 28 and 29 of the base member betweenthe barrier regions are elastomeric.

The foregoing structure provides a package for objects which must bekept aseptic, which is readily transportable, and which readily permitsthe use of one object by opening the package without affecting theaseptic quality of the remaining objects.

The terms and expressions which have been used, are used as terms ofdescription and not of limitation, and there is no intention in the useof such terms and expressions of excluding any equivalents of any of thefeatures shown or described, or portions thereof, but it is recognizedthat various modifications are possible within the scope of theinvention claimed. 2

I claim:

1. A device for holding andtransportin-g small objects in an asepticcondition including an enclosed sheath member, said sheath member beingflexible, fluid impervious, and including at least two compartmentshaving a border therebetween, said compartments being fluid imperviousat said border, a unitary base member projecting through eachcompartment, said base member being fluid porous within each compartmentand fluid impervious at the border of each compartment, whereby each ofsaid compartments is completely fluid impervious relative to theadjacent compartment and relative to the atmosphere.

2. A device according to claim 1, including at least two objects, eachobject being disposed in respective of said compartments, whereby theobjects are sealed from each other and from the outer atmosphere.

3. A device according to claim 2, wherein a portion of each object isdisposed in the base member.

4. A device according to claim 3, including an outer, openable,protective cover at least partially surrounding the sheath member.

5. A device according to claim 3, wherein the base member ispolyurethane.

6. A device according to claim 3, wherein the border is heat sealed.

7. A device according to claim 3, wherein the border is chemicallysealed.

8. A device according to claim 3, wherein the applicating medium is alubricant.

9. A device according to claim 1, including an applicating mediumdisposed within said base member in the said fluid porous portions, saidsheath member and said base member coacting at said border to preventmigration of the applicating medium from one compartment to another saidporous portions permitting migration of the applicating medium into thecompartment in which each such porous portion is disposed.

10. A device according to claim 9, wherein the applicating medium is anantiseptic.

11. A device according to claim 1, wherein the said border adjacent thebase member is comprised of a laminate-like structure comprising onelayer of the sheath member, a portion of the base member which is ofhigher density than the adjacent portions of the base member so as toform a barrier region, and an other layer of the sheath member, each ofsaid sheath layers partially circumscribing said higher density portionof said base member and being in abutting engagement on either side ofsaid higher density portion whereby the said layers coact to completelysurround said higher density portion of the base member in fluidimpervious engagement.

12. A device according to claim 11, wherein the remainder of said borderis comprised of a lamination of said one layer and said other layer ofthe sheath member.

13. A device according to claim 11, wherein the barrier region issufficiently dense to he impervious to moisture.

14. A device according to claim 1, wherein the unitary base member iselastomeric between the barrier regions and rigid at the barrierregions.

15. A device according to claim 1, wherein said seal between eachcompartment has a width sufiicient to enable a. compartment to bedetached from an adjacent compartment without destroying the sealbetween the remaining compartments and the atmosphere.

16. A device according to claim 1, including air disposed within each ofsaid compartments.

17. A device according to claim 1, wherein the sheath member iscomprised of a flexible polymeric material.

18. A method of packaging objects for transport in an aseptic conditionincluding the steps of placing an applicating medium in a base member,placing at least two spaced objects in position relative to said basemember, covering said base member and objects with an outer sheath ofpolymeric material, sealing the periphery of said outer sheath,transforming a portion of the base member along a line which, whenextended lies between said objects into a barrier region of sufiicientlyhigh density to prevent migration of said applicating medium throughsaid barrier region after the said transformation occurs, and sealingthe said layers to each other and to the said barrier region along acontinuation of said line so that the said barrier region and layerscoact to form a unitary fluid-impervious compartment wall.

19. A method according to claim 18, wherein the transforming stepincludes the application of heat and pressure along the said line.

20. A method of making a compartmentalized package having an applicatingmedium disposed therein including the steps of placing a thin layer ofpolymeric material on either side of an elongated sponge-like basemember having an applicating medium disposed therein, sealing the layersof polymeric material at spaced lines transverse of the elongated basemember to transform the portion of the base member adjacent said linesinto barrier regions of sufliciently high density to prevent migrationof said applicating medium through said barrier regions after the saidtransformation occurs, and sealing the said layers to each other and tothe said barrier region along said lines so that the said barrierregions and layers coact to form unitary fluid-impervious spacedcompartment Walls.

21. A multi-compartment package device adapted for holding and/ortransporting objects in an aseptic condition comprising, a flexible,relatively thin walled sheath, said sheath being sealed adjacent itsmarginal edges to provide an enclosed fluid impervious package, aunitary base member disposed in said sheath adjacent one end thereof, aplurality of laterally spaced sealing means an tending from one edge ofsaid sheath and transversely of said base member to an opposite edge ofsaid sheath, said sealing means providing with the base member barrierregions which define a plurality of substantially fluid imperviouscompartments therebetween, a portion of said base member projecting intoeach of the respective compartments with said projecting portions beingstructurally fluid porous within said compartments and structurallyfluid impervious at said barrier regions.

22. A multi-compartment package device according to claim 21, whereinsaid sealing means includes Weakened tear means so that a selective oneof said compartments can be removed, as a unit, from an adjacentcompartment without impairment to the substantially fluid imperviouscharacter of the removed compartment and to the remaining compartments.

23. A multi-compartment package device according to claim 21 whereinsaid sheath is comprised of a relatively thin walled polymeric material,and wherein said base member has a substantially greater cross-sectionaldimension as compared to the cross-sectional thickness of the respectivesheath walls.

24. A multi-compartment package device according to claim 21, whereinthe portions of said base member projecting within the respectivecompartments have a substantially greater cross-sectional dimension ascompared to the cross-sectional dimension of the portions at saidbarrier regions.

References Cited UNITED STATES PATENTS 616,042 12/1898 YVelsh. 2,268,37912/1941 Bird et al 206-56 X 3,080,963 3/1963 Rothgart 206O.84

THERON E. CONDON, Primary Examiner. J. M. CASKIE, Assistant Examiner.

1. A DEVICE FOR HOLDING AND TRANSPORTING SMALL OBJECTS IN AN ASEPTICCONDITION INCLUDING AN ENCLOSED SHEATH MEMBER, SAID SHEATH MEMBER BEINGFLEXIBLE, FLUID IMPERVIOUS, AND INCLUDING AT LEAST TWO COMPARTMENTSHAVING A BORDER THEREBETWEEN, SAID COMPARTMENTS BEING FLUID IMPERVIOUSAT SAID BORDER, A UNITARY BASE MEMBER PROJECTING THROUGH EACHCOMPARTMENT, SAID BASE MEMBER BEING FLUID POROUS WITHIN EACH COMPARTMENTAND FLUID IMPERVIOUS AT THE BORDER OF EACH COMPARTMENT, WHEREBY EACH OFSAID COMPARTMENTS IS COMPLETELY FLUID IMPERVIOUS RELATIVE TO THEADJACENT COMPARTMENT AND RELATIVE TO THE ATMOSPHERE.